Metastatic Castration-resistant Prostate CancerNCT04000776
3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Université de Sherbrooke at 5 sites in Canada.
Trial summary
Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- FDG Positron emission tomography (PET) scan, PSMA Positron emission tomography (PET) scan and OCTREOTATE Positron emission tomography (PET) scan
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 16 Dec 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients will be enrolled in five tertiary hospital centers (CIUSSSE-CHUS, CHUQc-UL, CHUM, CIUSSS-COMTL, and MUHC) of the province of Quebec
Who may be able to join
- Male ≥ 18 years old
- Histologically or cytologically proven PCa with or without neuroendocrine differentiation at initial diagnosis
- Castration-resistant prostate cancer with serum testosterone ≤ 50 ng/dL (1.73 nM) anytime while on androgen deprivation therapy
- Evidence of disease progression on prior therapy or watchful waiting. Disease progression is defined by meeting at least one of the following criteria:
- PSA progression defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥1ng/ml.
- Soft tissue disease ONLY progression* defined by RECIST 1.1: 1) at least 20% increase in the diameter of target lesions and 2) an absolute increase of ≥ 5 mm of the sum.
Show all 14Show fewer
- Soft tissue disease ONLY progression* defined as the appearance of at least one new lesion (soft tissue).
- Bone disease ONLY progression* defined by two or more new lesions on bone scan.
- Metastatic disease documented by at least 3 active lesions on whole body bone scan and/or measurable soft tissue on CT-scan (lymph nodes and visceral lesions). Metastatic lesions on imaging are defined by RECIST 1.1, either:
- ≥ 10 mm on CT scan or caliper (for lymph nodes, see below)
- ≥ 20 mm on chest X-ray
- lymph node ≥ 15 mm or ≥ 10 mm and having grown by ≥ 5 mm from baseline CT
- any metastasis described on bone scan counts as a lesion
- Able and willing to provide signed informed consent in French or English and to comply with protocol requirements.
Who cannot join
- Another non-cutaneous malignancy or melanoma diagnosed in the past 5 years;
- Currently under a randomized-controlled trial with unknown allocation;
- Limited survival prognosis (ECOG ≥3);
- Patients under dialysis;
- Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
CHUM, Université de Montréal
Montreal, Quebec, H2X0C1
McGill University Health Centre
Montreal, Quebec, H4A3J1
CIUSSS du Centre-Ouest-de -l'île-de-Montreal (CIUSSS-COMTL)
Montreal, Quebec
CHU de Québec - Université Laval (CRCHUQc-UL),
Québec, Quebec, G1R 3S1
Centre de recherche du CHUS (CRCHUS), Division of Urology, CIUSSS de l'Estrie - CHUS (CIUSSSE-CHUS)
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Triple-tracer Molecular Imaging Using 18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE to Characterize Metastatic Castration-resistant Prostate Cancer (mCRPC) and Evaluate Eligibility for Radionuclide Therapies
Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Treatment failure and poor progression-free survival could be explained by the fact that PCa metastases in the same patient may be polyclonal, showing opposite responses to systemic therapies.
This project aims to recruit 100 patients with mCRPC in order to determine the prevalence of intrapatient intermetastasis polyclonality and NED using PET/CT triple-tracer PSMA/FDG/OCTREOTATE imaging and eligibility for either PSMA or OCTREOTATE radioligand therapy (RLT).
Read the detailed description
Introduction: Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Of the five treatments approved for mCRPC patients, none has been shown to increase median overall survival beyond 4.8 months. Treatment failure and poor progression-free survival could be explained by the fact that PCa metastases in the same patient may be polyclonal, showing opposite responses to systemic therapies. Indeed, neuroendocrine differentiation from adenocarcinoma is often reported in metastatic PCa, which is associated with increased disease aggressiveness. Currently, no molecular tools are available to follow non-invasively mCRPC transdifferentiation and diagnose patients with neuroendocrine and/or polyclonal PCa. Positron emission tomography (PET) is a promising type of imaging using radio-labeled tracers to specifically identify tumour cells.
Hypothesis: The hypothesis of the 3TMPO clinical study is that the prevalence of intrapatient intermetastasis polyclonality can be diagnosed by combining 18F-FDG to other specific PET tracers that have the ability to non-invasively differentiate CRPC adenocarcinoma (CRPC-Adeno) (68Ga-PSMA) from neuroendocrine CRPC (CRPC-NE) tumours (68Ga-OCTREOTATE).
Objectives: The study objectives are to determine, in mCRPC patients, the prevalence of intrapatient intermetastasis polyclonality and NED using PET/CT triple tracer PSMA/FDG/OCTREOTATE imaging and their eligibility for radioligand therapy (RLT).
Method: This multicentre observational clinical study, for which prevalence of intrapatient intermetastasis polyclonality was set as the primary outcome, will recruit 100 mCRPC patients at 5 different sites across the province of Québec. 68Ga-PSMA and 18F-FDG PET scans will be performed on all enrolled patients, while 68Ga-OCTREOTATE will be performed on those presenting at least one PSMA-negative/FDG-positive lesion. The uptake of each individual lesion will be assessed for each PET tracer and patients with lesions presenting discordant uptake profiles will be considered as having polyclonal disease. OCTREOTATE-positivity will confirm the presence of CRPC-NE. PSMA or OCTREOTATE positivity of all lesions (or at least those with FDG uptake) will determine the eligibility for PSMA and OCTREOTATE RLT, respectively.
Relevance: Paradigm-shifting diagnostic and therapeutic strategies are urgently needed to improve the survival of patients with PCa and to deepen our understanding of mCRPC progression.
- Being tested
- FDG Positron emission tomography (PET) scan, PSMA Positron emission tomography (PET) scan, OCTREOTATE Positron emission tomography (PET) scan, Optional Bone or soft-tissue biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG Positron emission tomography (PET) scanDiagnostic test
Patients will undergo 18F-FDG and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases).
The patient will be measured and weighed before the exam in order to calculate a personalized dose. An intravenous catheter will be put in place in peripheral vein to allow injection of the tracer.
PSMA Positron emission tomography (PET) scanDiagnostic test
Patients will sequentially undergo 68Ga-PSMA and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases).
OCTREOTATE Positron emission tomography (PET) scanDiagnostic test
In the case a patient would present at least one PSMA-negative/FDG-positive lesion, he will be referred to undertake a whole-body 68Ga-OCTREOTATE PET/CT within 10 days of the first PET/CT. The delay between this third PET scan and the last one should be minimal (not least than 18 hours, not more than 10 days).
Images and data will be reviewed centrally within 4 days by the Imaging Corelab, which will produce a final report confirming patient's eligibility to Radioligand therapy (RLT).
Optional Bone or soft-tissue biopsiesOther
Patients presenting FDG-positive/PSMA-negative or Octreotate-positive lesions on imaging will be asked to undergo a biopsy of these lesions (optional) for research purposes. Bone or soft-tissue biopsies will be collected by an interventional radiologist according to site's standard-of-care procedure and sent to the local pathology department for preparation (formalin-fixed and paraffin-embedded); the blocks being sent to the Pathology Corelab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of INTRAPATIENT INTERMETASTATIC HETEROGENEITY
A patient with at least two lesions with discordant FDG/PSMA/OCTREOTATE multi-tracer imaging phenotypes.
Measured: Baseline
Proportion of neuroendocrine lesion
Neuroendocrine lesion DEFINITION: A patient with at least one OCTREOTATE-positive lesion or histopathological features of neuroendocrine differentiation
Measured: Baseline
Proportion of eligible patients for PSMA-RLT or OCTREOTATE-RLT
Eligibility for PSMA RLT is defined as : Having (1) at least one lesion that is PSMA-positive, and (2) no lesion that is PSMA-negative and FDG-positive. Eligibility for Octreotate RLT: Having (1) at least one lesion that is Octreotate-positive, and (2) no lesion that is Octreotate-negative and FDG-positive.
Measured: Baseline
Secondary outcomes (6)
18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE positive lesions
POSITIVE LESION: 18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE lesion uptake will be defined as positive if greater than that of the liver [18,19]. Using quantitative imaging methods, standardized uptake value ratio (SUVR, i.e. the ratio between lesion uptake (SUVpeak) over liver uptake (SUVmean)) will be obtained for each lesion with each tracer. For a given tracer, lesion positivity is defined as a SUVR equal or superior to 1.5.
Measured: Baseline
histologic NED status of lesions
positive histology to synaptophysin
Measured: Baseline
Pain score
Using a Brief Pain Index (BPI) questionnaire. The severity can be expressed through 4 aspects: worst, least, average and now. The pain interference with daily activities can be represented with 7 aspects: general activity, walking, work, mood, enjoyment of life, relationships and sleep.
Measured: Baseline and 3-months post-enrolment
Physical function
Using EQ5D questionnaire which use a 5-scale and evaluates 5 aspects: mobility, selfcare, activity, pain, anxiety and global self-evaluation.
Measured: Baseline and 3-months post-enrolment
Disease-associated symptoms
using FACT-P questionnaire: with subscale specific for wellbeing on physical, social/family, emotional functional and prostate aspects.
Measured: Baseline and 3-months post-enrolment
PET-tracer uptake derived parameters
such as SUVmax, SUV mean, sum of SUVmax
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start16 Dec 2019
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Oncopole, Canadian Cancer Society (CCS), Merck Canada Inc.
- Responsible party
- Sponsor
- Investigators
- Brigitte Guérin, Ph.D, Principal investigator, Department of Nuclear Medicine,Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000776
- Sponsor's protocol ID
- 3TMPO
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2019
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zamanian A, Rousseau E, Buteau FA, Arsenault F, Beaulieu A, April G, Juneau D, Plouznikoff N, Turcotte EE, Allard C, Richard PO, Saad F, Guerin B, Pouliot F, Beauregard JM. The tumour sink effect on 68Ga-PSMA-PET/CT in metastatic castration-resistant prostate cancer and its implications for PSMA-RPT: a sub-analysis of the 3TMPO study. Cancer Imaging. 2025 Jul 15;25(1):91. doi: 10.1186/s40644-025-00910-z.
PubMed 40665456Pouliot F, Saad F, Rousseau E, Richard PO, Zamanian A, Probst S, Levesque E, Castonguay V, Marcoux N, Lodde M, Juneau D, Hamilou Z, Lattouf JB, Buteau FA, Pavic M, Castilloux JF, Neveu B, Bouvet GF, Allard C, Tetu A, Guerin B, Beauregard JM; 3TMPO Investigators. Intrapatient Intermetastatic Heterogeneity Determined by Triple-Tracer PET Imaging in mCRPC Patients and Correlation to Survival: The 3TMPO Cohort Study. J Nucl Med. 2024 Nov 1;65(11):1710-1717. doi: 10.2967/jnumed.124.268020.
PubMed 39327017
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-tracer Molecular Imaging Using 18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE to Characterize Metastatic Castration-resistant Prostate Cancer (mCRPC) and Evaluate Eligibility for Radionuclide Therapies
- ClinicalTrials.gov ID
- NCT04000776
- Acronym / sponsor ID
- 3TMPO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Oncopole, Canadian Cancer Society (CCS), Merck Canada Inc.
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Treatment failure and poor progression-free survival could be explained by the fact that PCa metastases in the same patient may be polyclonal, showing opposite responses to systemic therapies.
This project aims to recruit 100 patients with mCRPC in order to determine the prevalence of intrapatient intermetastasis polyclonality and NED using PET/CT triple-tracer PSMA/FDG/OCTREOTATE imaging and eligibility for either PSMA or OCTREOTATE radioligand therapy (RLT).
Detailed description
Introduction: Prostate cancer (PCa) is the most common solid organ cancer in North American men. Patients becoming refractory to loco-regional therapy receive androgen deprivation therapy, but their disease will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC). Of the five treatments approved for mCRPC patients, none has been shown to increase median overall survival beyond 4.8 months. Treatment failure and poor progression-free survival could be explained by the fact that PCa metastases in the same patient may be polyclonal, showing opposite responses to systemic therapies. Indeed, neuroendocrine differentiation from adenocarcinoma is often reported in metastatic PCa, which is associated with increased disease aggressiveness. Currently, no molecular tools are available to follow non-invasively mCRPC transdifferentiation and diagnose patients with neuroendocrine and/or polyclonal PCa. Positron emission tomography (PET) is a promising type of imaging using radio-labeled tracers to specifically identify tumour cells.
Hypothesis: The hypothesis of the 3TMPO clinical study is that the prevalence of intrapatient intermetastasis polyclonality can be diagnosed by combining 18F-FDG to other specific PET tracers that have the ability to non-invasively differentiate CRPC adenocarcinoma (CRPC-Adeno) (68Ga-PSMA) from neuroendocrine CRPC (CRPC-NE) tumours (68Ga-OCTREOTATE).
Objectives: The study objectives are to determine, in mCRPC patients, the prevalence of intrapatient intermetastasis polyclonality and NED using PET/CT triple tracer PSMA/FDG/OCTREOTATE imaging and their eligibility for radioligand therapy (RLT).
Method: This multicentre observational clinical study, for which prevalence of intrapatient intermetastasis polyclonality was set as the primary outcome, will recruit 100 mCRPC patients at 5 different sites across the province of Québec. 68Ga-PSMA and 18F-FDG PET scans will be performed on all enrolled patients, while 68Ga-OCTREOTATE will be performed on those presenting at least one PSMA-negative/FDG-positive lesion. The uptake of each individual lesion will be assessed for each PET tracer and patients with lesions presenting discordant uptake profiles will be considered as having polyclonal disease. OCTREOTATE-positivity will confirm the presence of CRPC-NE. PSMA or OCTREOTATE positivity of all lesions (or at least those with FDG uptake) will determine the eligibility for PSMA and OCTREOTATE RLT, respectively.
Relevance: Paradigm-shifting diagnostic and therapeutic strategies are urgently needed to improve the survival of patients with PCa and to deepen our understanding of mCRPC progression.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients will be enrolled in five tertiary hospital centers (CIUSSSE-CHUS, CHUQc-UL, CHUM, CIUSSS-COMTL, and MUHC) of the province of Quebec
Key inclusion criteria (14 listed)
- Male ≥ 18 years old
- Histologically or cytologically proven PCa with or without neuroendocrine differentiation at initial diagnosis
- Castration-resistant prostate cancer with serum testosterone ≤ 50 ng/dL (1.73 nM) anytime while on androgen deprivation therapy
- Evidence of disease progression on prior therapy or watchful waiting. Disease progression is defined by meeting at least one of the following criteria:
- Metastatic disease documented by at least 3 active lesions on whole body bone scan and/or measurable soft tissue on CT-scan (lymph nodes and visceral lesions). Metastatic lesions on imaging are defined by RECIST 1.1, either:
Key exclusion criteria (5 listed)
- Another non-cutaneous malignancy or melanoma diagnosed in the past 5 years;
- Currently under a randomized-controlled trial with unknown allocation;
- Limited survival prognosis (ECOG ≥3);
- Patients under dialysis;
- Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG Positron emission tomography (PET) scanPatients will undergo 18F-FDG and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases). The patient will be measured and weighed before the exam in order to calculate a personalized dose. An intravenous catheter will be put in place in peripheral vein to allow injection of the tracer. | Diagnostic test | – |
| PSMA Positron emission tomography (PET) scanPatients will sequentially undergo 68Ga-PSMA and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases). | Diagnostic test | – |
| OCTREOTATE Positron emission tomography (PET) scanIn the case a patient would present at least one PSMA-negative/FDG-positive lesion, he will be referred to undertake a whole-body 68Ga-OCTREOTATE PET/CT within 10 days of the first PET/CT. The delay between this third PET scan and the last one should be minimal (not least than 18 hours, not more than 10 days). Images and data will be reviewed centrally within 4 days by the Imaging Corelab, which will produce a final report confirming patient's eligibility to Radioligand therapy (RLT). | Diagnostic test | – |
| Optional Bone or soft-tissue biopsiesPatients presenting FDG-positive/PSMA-negative or Octreotate-positive lesions on imaging will be asked to undergo a biopsy of these lesions (optional) for research purposes. Bone or soft-tissue biopsies will be collected by an interventional radiologist according to site's standard-of-care procedure and sent to the local pathology department for preparation (formalin-fixed and paraffin-embedded); the blocks being sent to the Pathology Corelab. | Other | – |
Primary outcome
Prevalence of INTRAPATIENT INTERMETASTATIC HETEROGENEITY
Time frame: Baseline
A patient with at least two lesions with discordant FDG/PSMA/OCTREOTATE multi-tracer imaging phenotypes.
Proportion of neuroendocrine lesion
Time frame: Baseline
Neuroendocrine lesion DEFINITION: A patient with at least one OCTREOTATE-positive lesion or histopathological features of neuroendocrine differentiation
Proportion of eligible patients for PSMA-RLT or OCTREOTATE-RLT
Time frame: Baseline
Eligibility for PSMA RLT is defined as : Having (1) at least one lesion that is PSMA-positive, and (2) no lesion that is PSMA-negative and FDG-positive. Eligibility for Octreotate RLT: Having (1) at least one lesion that is Octreotate-positive, and (2) no lesion that is Octreotate-negative and FDG-positive.
6 secondary outcomes
18F-FDG, 68Ga-PSMA and 68Ga-OCTREOTATE positive lesions
Time frame: Baseline
histologic NED status of lesions
Time frame: Baseline
Pain score
Time frame: Baseline and 3-months post-enrolment
Physical function
Time frame: Baseline and 3-months post-enrolment
Disease-associated symptoms
Time frame: Baseline and 3-months post-enrolment
PET-tracer uptake derived parameters
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Derived from this study: PubMed 40665456Zamanian A, Rousseau E, Buteau FA, Arsenault F, Beaulieu A, April G, Juneau D, Plouznikoff N, Turcotte EE, Allard C, Richard PO, Saad F, Guerin B, Pouliot F, Beauregard JM. The tumour sink effect on 68Ga-PSMA-PET/CT in metastatic castration-resistant prostate cancer and its implications for PSMA-RPT: a sub-analysis of the 3TMPO study. Cancer Imaging. 2025 Jul 15;25(1):91. doi: 10.1186/s40644-025-00910-z.
- Derived from this study: PubMed 39327017Pouliot F, Saad F, Rousseau E, Richard PO, Zamanian A, Probst S, Levesque E, Castonguay V, Marcoux N, Lodde M, Juneau D, Hamilou Z, Lattouf JB, Buteau FA, Pavic M, Castilloux JF, Neveu B, Bouvet GF, Allard C, Tetu A, Guerin B, Beauregard JM; 3TMPO Investigators. Intrapatient Intermetastatic Heterogeneity Determined by Triple-Tracer PET Imaging in mCRPC Patients and Correlation to Survival: The 3TMPO Cohort Study. J Nucl Med. 2024 Nov 1;65(11):1710-1717. doi: 10.2967/jnumed.124.268020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Guérin, Ph.D principal investigator
Department of Nuclear Medicine,Université de Sherbrooke
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Université de Sherbrooke at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of INTRAPATIENT INTERMETASTATIC HETEROGENEITY (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.